Quality Assurance GMP Italy
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* Maintain compliance with GMP requirements and applicable quality regulations across manufacturing processes and finished products.
* Review, develop and update SOPs, work instructions and quality documentation, ensuring these are followed consistently in daily operations.
* Assess production and batch documentation for accuracy and compliance, taking appropriate action when products do not meet release requirements.
* Investigate quality incidents and deviations, work with relevant departments to identify root causes, and ensure corrective and preventive actions are implemented effectively.
* Manage customer complaints, oversee investigations and coordinate the implementation of appropriate CAPAs.
* Plan and perform internal audits, document findings and ensure agreed improvements are completed.
* Coordinate external audits and inspections by customers and regulatory authorities, including preparation, responses and follow-up activities.
* Compile annual product quality reviews, assess quality system performance and prepare required reports and management information.
* Support quality-related discussions with internal teams and external partners, including the preparation and review of quality agreements.
* Advise production teams on quality requirements, promote GMP awareness and encourage a strong quality culture throughout the organization.
* Identify opportunities to improve Quality Assurance processes, monitor relevant KPIs and contribute to departmental performance reporting.
Your profile
* A bachelor’s or master’s degree in a relevant scientific or technical discipline.
* At least five years of Quality Assurance experience / GMP-regulated environment in pharma / biotech
* Practical knowledge of GMP requirements, audit processes, deviation management and CAPA system #J-18808-Ljbffr
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